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Firefly Neuroscience (NASDAQ: AIFF) Reports 291% Increase in TMS Center Customer Brain Scan Volumes

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Firefly Neuroscience (NASDAQ: AIFF) reported a 291% year-over-year increase in TMS center customer clinical assessments using its FDA 510(k)-cleared, AI-powered EEG/ERP platform, Evoke. The system combines quantitative EEG (qEEG) and event-related potentials (ERP) to provide a more complete view of brain activity in clinical settings.

In TMS centers, Evoke brain scans display electrophysiological signals that physicians may use to assess patterns commonly associated with depression and mood disorders, anxiety disorders, and ADHD/attention-related conditions. According to the company, this supports more individualized TMS treatment decisions, treatment monitoring over time, and objective evidence of treatment response. Firefly also highlights a proprietary database of over 200,000 standardized EEG/ERP brain scans that underpins its precision neuroscience approach.

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Positive

  • TMS center Evoke assessments increased 291% year-over-year
  • FDA 510(k)-cleared AI-powered Evoke EEG/ERP platform in clinical use
  • 200,000+ standardized EEG/ERP brain scans in proprietary database

Negative

  • None.

Market Context

The stock is up +9.2% following this news. AIFF previously gained 6% after the April 13 scan milesto...
Analysis

The stock is up +9.2% following this news. AIFF previously gained 6% after the April 13 scan milestone, providing a comparable platform datapoint for this volume update. The active S-3/A is a resale registration, while low short positioning remained a separate risk.

Key Figures

TMS customer assessment increase: 291% FDA clearance: 510(k) EEG/ERP brain scans: over 200,000 brain scans
3 metrics
TMS customer assessment increase 291% Year-over-year increase in TMS center customer clinical assessments
FDA clearance 510(k) Evoke EEG/ERP platform
EEG/ERP brain scans over 200,000 brain scans Firefly's proprietary database

Historical Context

5 past events · Latest: Jul 28 (Positive)
Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Jul 28 Strategic partnership Positive -6.4% Partnership linked Firefly's platform with Next Health and peptide-based cognitive care.
Jun 02 Biomarker discovery Positive +4.1% Reported novel electrophysiological biomarker discovery for PTSD using Evoke.
Apr 13 Scan volume milestone Positive +6.0% Surpassed 200,000 standardized EEG/ERP scans with sequential volume growth.
Mar 26 Defense partnership Positive +79.8% Announced defense health partnership deploying Evoke for PTSD and TBI assessment.
Mar 13 ADHD biomarker discovery Positive +58.0% Reported AI-discovered brain wave biomarkers intended to distinguish ADHD subtypes.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Firefly's positive announcements generally aligned with gains, although the July 28 partnership announcement diverged with a negative reaction.

Key Terms

transcranial magnetic stimulation, qEEG, ERP, 510(k)
4 terms
transcranial magnetic stimulation medical
"Transcranial Magnetic Stimulation (“TMS”) center customer clinical assessments"
A noninvasive medical treatment that uses a changing magnetic field delivered through a coil placed near the head to stimulate specific areas of the brain, much like tapping a piano key to make a particular note play. Investors care because devices, clinical trial results, insurance coverage, and regulatory approvals determine commercial adoption and revenue potential for makers of the machines, clinics that offer the therapy, and related healthcare suppliers.
qEEG medical
"By combining qEEG and ERP, Evoke™ provides a more complete view of brain activity"
Quantitative electroencephalography (qEEG) is a medical technique that records the brain’s electrical signals with sensors and uses computer analysis to convert those signals into visual maps and numeric patterns—like turning the brain’s radio waves into a visual equalizer. For investors, qEEG matters because its accuracy, clinical acceptance and regulatory or insurance support can drive demand for related diagnostic devices, therapies and services, affecting revenue potential and regulatory risk.
ERP medical
"By combining qEEG and ERP, Evoke™ provides a more complete view of brain activity"
ERP, or Enterprise Resource Planning, is a comprehensive software system that helps organizations manage and integrate core business processes such as finance, supply chain, and human resources in one unified platform. For investors, ERP systems can indicate how efficiently a company operates; strong and well-integrated systems often suggest good management and potential for sustainable growth.
510(k) regulatory
"U.S. Food and Drug Administration (“FDA”) 510(k)-cleared"
A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Commercial momentum continues to build, while Firefly harnesses increased electrophysiological data combining EEG and ERG to unlock future value

KENMORE, N.Y., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence ("AI") company advancing precision neuroscience, today announced a close to four-fold (291%) year-over-year increase in Transcranial Magnetic Stimulation (“TMS”) center customer clinical assessments using its U.S. Food and Drug Administration (“FDA”) 510(k)-cleared, AI-powered EEG/ERP platform, Evoke™.

By combining qEEG and ERP, Evoke™ provides a more complete view of brain activity, designed to help clinicians identify patterns, differentiate conditions when symptoms overlap, and evaluate brain function with greater clarity. Within the TMS center setting in particular, Firefly’s EEG/ERP brain scans display electrophysiological signals that physicians may use to assess patterns commonly associated with psychiatric and behavioral health conditions, including:

  • Depression and mood disorders;
  • Anxiety disorders; and
  • ADHD and attention-related conditions.

By understanding how each patient’s brain is functioning, clinicians may tailor TMS treatments more precisely, adjust care based on response, and better align treatment strategies to the patient’s specific needs.

“As demonstrated by this significant expansion of TMS center customer adoption of Evoke, we continue to successfully execute against the key pillars of our growth strategy,” said Greg Lipschitz, Firefly’s Chief Executive Officer. “Our vision is to harness the full potential of EEG/ERP brain scans and assessments to guide more individualized treatment decisions. Evoke empowers clinicians to track changes in brain function over time to understand how patients are responding to treatment.”

“By assessing brain activity before, during, and after care, clinicians can make earlier, more informed adjustments and ensure interventions are aligned with how the brain is actually changing,” added Mr. Lipschitz. “Importantly, this may also enable TMS centers to provide their patients with objective evidence that their treatments are working, sometimes even before they feel better, thereby helping to maintain compliance with the multi-session therapy.”

About Firefly Neuroscience

Firefly Neuroscience, Inc. (NASDAQ: AIFF) is an Artificial Intelligence ("AI") company advancing precision neuroscience, applying AI and large-scale electrophysiological data to give clinicians a more complete, objective picture of how an individual patient's brain is functioning. Firefly's proprietary database consists of over 200,000 EEG/ERP brain scans, which the Company believes to be the world's largest known standardized EEG/ERP repository. Firefly's EEG-based, AI-driven, and FDA-510(k)-cleared Evoke System is designed to support diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, ADHD, and PTSD.

Please visit www.fireflyneuro.com for more information.

Forward-Looking Statements

Certain statements in this press release may constitute "forward-looking statements" for purposes of the federal securities laws concerning Firefly, including statements relating to Firefly's management team's expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "contemplate," "continue," "could," "estimate," "expect," "intends," "may," "might," "plan," "possible," "potential," "predict," "project," "should," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly's control) and other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, those factors described under the heading "Risk Factors" in the reports and other filings of Firefly with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of Firefly's assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.

Investor & Media Contact

Stephen Kilmer
(646) 274-3580
stephen.kilmer@fireflyneuro.com


FAQ

What did Firefly Neuroscience (NASDAQ: AIFF) announce about TMS center brain scan volumes on August 5, 2026?

Firefly Neuroscience announced a 291% year-over-year increase in TMS center customer clinical assessments using its Evoke EEG/ERP platform. According to the company, this reflects growing adoption of its FDA 510(k)-cleared, AI-powered system to support brain function assessment and treatment monitoring in psychiatric and behavioral health care.

How does Firefly Neuroscience’s Evoke platform support TMS treatments for AIFF customers?

Evoke combines qEEG and ERP to give clinicians a more complete view of brain activity for TMS patients. According to Firefly, physicians may use Evoke brain scans to assess patterns linked with depression, anxiety, and ADHD, tailoring TMS treatments and adjusting care based on how brain function changes over time.

Which conditions can Firefly Neuroscience’s Evoke system help clinicians evaluate?

Evoke is designed to support assessment and treatment monitoring for psychiatric and neurological conditions. According to Firefly, clinicians may use its EEG/ERP platform for conditions such as depression, dementia, anxiety disorders, concussions, ADHD, PTSD, and other mood and attention-related disorders in clinical practice.

What regulatory status does the Firefly Neuroscience Evoke system have as of August 2026?

The Evoke system is FDA 510(k)-cleared as an EEG/ERP platform used in clinical assessments. According to Firefly, this AI-driven technology supports diagnostic and treatment monitoring methods by providing objective electrophysiological data on brain function to complement traditional clinical evaluation approaches for multiple brain-related conditions.

How large is Firefly Neuroscience’s EEG/ERP brain scan database supporting the AIFF Evoke platform?

Firefly reports a proprietary database of over 200,000 standardized EEG/ERP brain scans supporting its Evoke platform. According to the company, this large-scale electrophysiological dataset underpins its AI models and precision neuroscience approach, helping clinicians gain a more objective picture of individual brain function during assessment and treatment.

How might increased Evoke usage at TMS centers impact Firefly Neuroscience’s growth strategy?

The 291% year-over-year increase in Evoke clinical assessments at TMS centers aligns with Firefly’s growth pillars. According to the company, broader adoption helps demonstrate Evoke’s role in guiding individualized treatment decisions, supporting ongoing commercial momentum and expanding the clinical dataset used to refine its AI-driven neuroscience platform.